Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen ([Ga-68]PSMA) for characterization of prostate abnormalities.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norbert Avril, M.D.

Criteria

Inclusion Criteria:

• Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included.

• Able to tolerate PET/CT scans

• Informed consent must be given and signed

Exclusion Criteria:

• Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks

• Known allergy against Ga-68 PSMA

• Prior prostate biopsy within the last 2 weeks